The Role of Stem Cells on Immune Cells in the Development of Cardiovascular Diseases (ATHEROSTEM)

Radboud University Medical Center

Status: Completed

Conditions: Cardiovascular Diseases; Atherosclerosis

Study type: Observational

Funder types: Other

Identifiers

NCT03172507

NL58806.091.16

Details and patient eligibility

About

An observational pilot proof-of-principle study. 15 patients with significant coronary artery disease and 15 matched controls. To investigate whether long-term activation of the innate immune system, named 'trained innate immunity', occurs at the level of the bone marrow progenitor cells in patients with significant coronary artery disease and whether this correlates with the proinflammatory phenotype of monocytes.

Enrollment: 27 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥18 and ≤75 years
• With or without significant coronary artery disease on CCTA
• Written informed consent

Exclusion criteria

• Chronic infections
• Diabetes mellitus
• Medical history of any disease associated with immune deficiency
• Clinically significant infections within 3 months prior to study entry
• Recent hospital admission or surgery with general anaesthesia
• Known chronic kidney or liver disease
• Previous vaccination within 3 months prior to study entry
• Inability to personally provide written informed consent
• Inability to undergo PET-CT scanning
• Chronic use of anti-inflammatory drugs such as NSAIDs
• History of haematological malignant disease
• Documented bleeding diathesis or thrombocytopenia
• Pregnancy

Trial design

27 participants in 2 patient groups

Atherosclerosis group

Description:

Patients with significant coronary artery disease.

Control group

Description:

Healthy controls without confirmed coronary artery disease.